Multi-point tissue tension distribution device, a brow and face lift variation, and a method of tissue approximation using the device

ABSTRACT

A tissue approximation device and processes for using the device are provided. The device is an implantable, biodegradable construct (except for hernia repairs) that has attachment points emanating from a supportive backing. The device improves the mechanical phase of wound healing and evenly distributes tension over the contact area between the device and tissue. Processes for using the device include wound closure, vascular anastomoses, soft tissue attachment and soft tissue to bone attachment. Several variations are particularly applicable to facilitating tissue approximation in surgical cosmetic applications, particularly brow lifts. Generally, scalp tissue to be lifted may be set on a brow lift device via attachment points, and the device may then be secured to a patient&#39;s cranium. Variations of the device are described along with a method of installing the brow lift device. Also described is a tool particularly useful for installing a brow lift device.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This is a continuation of U.S. patent application Ser. No.09/788,118, filed Feb. 16, 2001, which is a continuation-in-part of U.S.patent application Ser. No. 09/574,603, filed May 19, 2000, each ofwhich is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] This invention is in the field of surgery. More particularly, itrelates to a tissue approximation device. By “approximation” we mean toinclude variously the specific movement of two regions of tissue towardseach other, the movement of one or more selected tissue regions orareas, the maintenance and/or fixation of one or more selected tissueregions in a selected position, and the maintenance and/or fixation of aselected area of tissue against shape variation due to tissue“springiness.” We will also refer to these functions as “stabilization”of a tissue region. For instance, the inventive device may be used tofacilitate wound healing by holding soft tissue together under improveddistribution of tension and with minimal disruption of the woundinterface and its nutrient supplies. Generally, the device has multiplesites for grasping said tissue using tines or prongs or other generallysharp, projecting points, extending from and preferably affixed to asingle, supportive backing. Various processes of using the inventivedevice are also a portion of the invention.

BACKGROUND OF THE INVENTION

[0003] The inventive device is preferably used for the approximation,mobilization, or fixation of tissue. As noted above, these terms aremeant variously to include the specific movement of two regions oftissue towards each other, the movement of one or more selected tissueregions or areas, the maintenance of one or more selected tissue regionsin a selected position, and the maintenance of a selected area of tissueagainst shape variation due to tissue “springiness.” Using our inventivedevice, a variety of approximation procedures may be achieved, variouslyfrom the movement of two tissue areas towards each other at a commonwound margin to the maintenance of an area of tissue in a specificposition during or after a surgical procedure, e.g. brow lifts or ACLregions.

[0004] For instance, our inventive device allows healing of soft tissuedue to its maintenance of tissue position. The surgically inducedhealing of soft tissue wounds involves two phases, the mechanical phaseof wound closure followed by the biochemical phase which involvesprotein bridging and scarring. In the mechanical phase, the edges ofsoft tissue are held in contact by essentially two components: 1) Thephysical properties and device-tissue interactions of the materialsholding the tissue edges in contact, e.g. sutures or staples; and 2) Anearly deposition of proteinaceous material that has adhesivecharacteristics, e.g. fibrin glue.

[0005] Only in the biochemical phase, which occurs after the mechanicalphase, do tissue components replace the mechanical components adheringthe wound surfaces. During the biochemical phase, the inflammatorycascade generates signals which induce fibroblasts to migrate into thewound and synthesize collagen fibers.

[0006] Collagen is the primary constituent of connective tissue andultimately determines the pliability and tensile strength of the healingwound. Tensile strength is gradually recovered; 60% of ultimate woundstrength is achieved after approximately 3 months. However, this processis successful only if the previous mechanical phase has proceedednormally.

[0007] The surgeon's goal is to optimize the strength and often thecosmetic appearance of a wound closure or tissue coaptation. For this tohappen, tissue is mechanically approximated until the wound has healedenough to withstand stress without artificial support. Optimal healingrequires the application of appropriate tissue tension on the closure toeliminate dead space but not create ischemia within the tissue. Both ofthese circumstances increase the risk of wound infection and wounddehiscence.

[0008] Although the biomaterial composition of sutures has progressedconsiderably, the sophistication of manual suture placement in woundshas advanced relatively little since the original use of fabrics severalthousand years ago to tie wound edges together. The wide toleranceranges for suture placement, tension, and configurations, both amongstdifferent surgeons and for different implementations by the samesurgeon, result in a significant component of sub-optimal technique.Yet, the technique used for wound closure forms the foundation for allsubsequent events in the healing process. It is during this mechanicalphase that tissue tension is high, edema and inflammation are intense,wound edge ischemia is greatest, and that one can already observe thecomplication of wound failure

[0009] Soft tissue is well known for its inability to hold tension. Evenwhen optimally placed, sutures gradually tear through soft tissue,producing gaps in wounds and possibly leading to the eventual failure orsub-optimization of wound healing. Furthermore, since sutures requirethe implementation of high levels of tension to counteract the forcesacting to separate tissues, they may strangulate the blood supply of thetissues through which they are placed, thus inhibiting the delivery ofwound nutrients and oxygen necessary for healing.

[0010] There have been many attempts to construct wound closure devicesthat decrease closure time and improve cosmesis. U.S. Pat. Nos.2,421,193 and 2,472,009 to Gardner; U.S. Pat. No. 4,430,998 to Harvey etal.; U.S. Pat. No. 4,535,772 to Sheehan; U.S. Pat. No. 4,865,026 toBarrett; U.S. Pat. No. 5,179,964 to Cook; and U.S. Pat. No. 5,531,760 toAlwafaie suggest such devices. However, these devices are not useful insurgical or deeper wounds. They only approximate the skin surface,joining skin edges variously through external approaches, usingadhesives or nonabsorbable attachment points that penetrate tissue. Thedevices minimally improve the biomechanics of wound closure, and do notadequately approximate the deeper layers of the closure, i.e. fascia ordermis. Externally placed attachment points that puncture the skinlateral to the wound also interfere with long-term cosmesis and providea possible conduit for infecting microorganisms.

[0011] U.S. Pat. No. 5,176,692 to Wilk et al., discloses a device forhernia repair that utilizes mesh with pin-like projections to coverhernia defects. This device, however, is used in a laparoscopic herniarepair in conjunction with an inflatable balloon. Closure devices fordeeper tissues are described in U.S. Pat. No. 4,610,250 to Green; U.S.Pat. No. 5,584,859 to Brozt et al.; and U.S. Pat. No. 4,259,959 toWalker. However, these devices either work in conjunction with sutures,are made of materials that do not suggest biodegradability, or aredesigned in such a way as not to impart uniform tension on the closure,increasing the risk of wound separation and failure of wound healing.

[0012] The present invention is a biodegradable tissue approximationdevice. The device includes a plurality of attachment points, e.g.tines, prongs, or other generally sharp or blunt parts, connected to abacking that can be manipulated to close wounds, join soft tissue orbone, or create anastomoses. This multi-point tension distributionsystem (MTDS) device may be placed with minimal tissue trauma. Thepresent invention typically incorporates the deeper layers of tissuewithin the closure, and the multiple attachment points distribute theresulting tension, often uniformly. Approximation from the internalaspect of the wound minimizes the potential for dead space in theclosure, thus decreasing the risk of sub-optimal healing. Moreover,because the device is absorbed, a second procedure is not typicallyneeded to remove the device.

[0013] Thus, the present invention improves the mechanical phase ofhealing by facilitating wound closure and/or the coaptation of tissuesprior to initiation of the biochemical phase of wound healing. Placementof the device maximizes the chance for a good cosmetic result and is notheavily dependent on surgeon skill. Closure time is also shortened,decreasing overall cost and risk of operative complications.

SUMMARY OF THE INVENTION

[0014] The present invention is a device that improves the mechanicalphase of wound healing. In the preferred embodiment, tissue edges arestabilized by a plurality of attachment points that extend from and areaffixed to a supportive backing. The density, shape, length, andorientation of attachment points on the backing may be varied to suitthe procedure, type of tissue being approximated, and/or area of thebody involved. The flexibility of the backing is also variable anddependent on the materials used and dimensions of the backing. Infunction, the forces or tension placed upon the tissues by the inventivedevice are mirrored in the backing of the device. Said another way, theshape of the tines relay any forces to the backing of the device. Thebacking is generally in shear along its length. In the preferredembodiment, the device is biodegradable, and the attachment pointsuniformly distribute tension over the contact area between the deviceand tissue.

[0015] Processes of using the present invention are also provided. Thedevice may be used to close wounds and create vascular anastomoses. Thedevice may also be manipulated to approximate soft tissue and softtissue to bone. The device may be used to mobilize, move, or stabilize aselected region or area of tissue, as noted above.

[0016] A further application may include approximation of soft tissue inbrow lift and other craniofacial and maxillofacial surgical procedures.Such a device may be optimized to distribute loads over the device whilethe device remains attached to the patient's cranium. The brow liftdevice may further include multiple variations of the device and ispreferably biodegradable and absorbable by the patient. The device mayalso be made from biological materials. A device variation may beinstalled into a patient by first creating an incision in the patient'sscalp. This incision is preferably a predetermined length correspondingto the length of scalp or tissue desired to be lifted. At one end of theincision, preferably the end farthest away from the scalp or tissue tobe lifted, the doctor or surgeon would drill a hole into the cranium. Atthe opposing end of the incision, the device may be inserted under thescalp or tissue which is then set on the device via attachment pointsaffixed to the device surface. The surgeon may then lift the scalp ortissue via the device, which may then be secured to the cranium byinserting an anchoring post into the drilled hole. Alternatively, afterthe incision is made and the hole drilled in the cranium, the device mayfirst be inserted into the hole via the post. The surgeon may then liftthe scalp or tissue into position over the device and then set thelifted tissue onto the attachment points.

[0017] In either case, the procedures may be accomplished by a varietyof methods. One particularly useful tool may comprise a manipulatablehandle having opposing grasping arms. The grasping arms may be used tosecure and handle the device via the anchoring post. The tool mayinclude a slidable block which may be angularyl disposed relative to thehandle so that the block may press down and secure a portion of thescalp or tissue to be lifted. The block is preferably disposed angularlysuch that the angle of the block is similar to the angle of theattachment points affixed to the brow lift device. Angling the block mayallow the tissue to be optimally set against the attachment points andmay provide the least resistance to piercing the scalp or tissue.Alternatively, the tool may omit the slidable block completely and thetissue may be set against the attachment points by other methods such assimply pressing against the tissue by hand.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIGS. 1A-1D are plan, perspective views of various MTDS devices.

[0019] FIGS. 2A-2E are side views of various attachment point shapes andorientations.

[0020] FIGS. 3A-3D and 3F-3G are side views of various attachmentpoints.

[0021]FIG. 3E is a side view of a two-sided MTDS device.

[0022]FIG. 3H is a plan, reverse perspective view of nubs on theinferior surface of a MTDS device.

[0023]FIG. 4A is a side, cross-sectional view of attachment points thatrun through the width of a backing.

[0024]FIG. 4B is a side view of attachment points on a strip of backingmaterial.

[0025]FIG. 4C is a plan, perspective view of the embodiment in 4B on abacking.

[0026]FIG. 4D is a plan, perspective view of attachment points on asolid backing.

[0027]FIG. 5A is a plan, perspective view of attachment points canted inone direction.

[0028] FIGS. 5B-5D are plan, perspective views of attachment points withvarious orientations on a backing.

[0029]FIG. 5E is a side view of attachment points becoming progressivelyshorter the closer they are to the center of the device.

[0030]FIG. 5F is a side view of attachment points becoming progressivelyshorter the farther they are from the center of the device.

[0031] FIGS. 6A-6B are schematic views of a skin wound and wound repairusing the MTDS device.

[0032]FIG. 7 is a schematic view of an abdominal wound closure usingMTDS devices.

[0033] FIGS. 8A-8B are schematic views of an abdominal hernia and herniarepair using the MTDS device.

[0034] FIGS. 8C-8D are side and schematic views, respectively, of a MTDSdevice with attachment points on the edges of the backing and a centralarea without attachment points.

[0035] FIGS. 9A-9B are schematic views of a ruptured tendon and tendonto bone repair using the MTDS device.

[0036]FIG. 10A is an axial view of a cross-section of a vessel repairedwith the MTDS device.

[0037] FIGS. 10B-10C are side, schematic views of vessel free ends and avascular anastomosis using the MTDS device.

[0038] FIGS. 11A and 11B-11C are schematic, side, and cross-sectionalside views, respectively, of a transected tendon and a tendon to tendonrepair using the MTDS device.

[0039]FIG. 11D is an axial, cross-sectional view of the MTDS tendon totendon repair.

[0040]FIG. 11E is a side view of a vascular anastomosis using the MTDSdevice on the external surface of a vessel.

[0041] FIGS. 11F-11G are side, schematic views, and FIG. 11H is an axialview of the ends of a tubular structure being joined by externallyplacing strips of a MTDS device on approximated tissue.

[0042]FIG. 11I is an axial view of a hinge in the backing of a device.

[0043] FIGS. 11J-11K are axial views of decreased backing material thatare areas of enhanced device flexibility.

[0044] FIGS. 11L-11M are side views of a spring or coil-like MTDS devicebeing used to approximate tissue.

[0045]FIG. 12A is a schematic view of the MTDS device being used in abrow-lift procedure.

[0046]FIG. 12B is a plan, perspective view of the MTDS device used in abrow-lift.

[0047]FIG. 13A is a front view of a variation of a MTDS device having anintegral post or anchor used in a brow-lift.

[0048] FIGS. 13B-13C are a top view and a side view, respectively, ofthe device of FIG. 13A showing the attachment points and integral post.

[0049]FIG. 13D is a perspective view of the device of FIG. 13A.

[0050]FIG. 13E is a view of cross-section 13E-13E from FIG. 13B showingthe cavities in the post.

[0051] FIGS. 14A-14D show a top view of a patient's cranium duringinsertion of the device of FIG. 13A.

[0052]FIG. 15 is a cross-sectional side view of the insertion andsecuring procedure of the MTDS device from FIG. 14C.

[0053] FIGS. 16A-16D are various views of an exemplary attachment pointfrom FIG. 13A.

[0054]FIG. 17A is a view from perspective 17A-17A from FIG. 13C of thepost having a partial collar.

[0055]FIG. 17B is a variation of FIG. 17A of the post having a fullcollar.

[0056]FIG. 17C is a variation of FIG. 17A of the post having severaltabs.

[0057] FIGS. 18A-18C show back, front, and side views of a postvariation missing a distal cavity.

[0058]FIG. 19A is a perspective view of the post from FIG. 18B showingthe proximal cavity within the post.

[0059]FIG. 19B is a view of cross-section 19B-19B from FIG. 18B showingthe proximal cavity.

[0060]FIG. 20 is a perspective view of a post variation having a beveledlatching mechanism.

[0061]FIG. 21 is a perspective view of another post variation having anintegral beveled latching mechanism.

[0062]FIG. 22A is a side view of a post variation having a rounded hook.

[0063]FIG. 22B is a side view of a post variation having an angled post.

[0064]FIG. 22C is a side view of the supportive backing defining a holeto receive a separate fastening device.

[0065] FIGS. 22D-22E are side views of a radially expandable postvariation.

[0066]FIG. 23A is a cross-sectional view of atypical hole in a patient'scranium for receiving a post.

[0067]FIG. 23B is a cross-sectional view of an angled hole variation forreceiving a post.

[0068]FIG. 23C is a cross-sectional view of a possible keyed holevariation for receiving a post.

[0069] FIGS. 24A-24C are top, side, and perspective views of analternative variation of the MTDS device.

[0070]FIG. 24D is a view of cross-section 24D-24D from FIG. 24A.

[0071] FIGS. 25A-25C are top, side, and back views of another variationof the MTDS device which may receive separatable attachment points.

[0072] FIGS. 26A-26C are top, side, and back views of a variation of theMTDS device having dual tabs on the post.

[0073] FIGS. 27A-27C are top, side, and back views of a variation of theMTDS device having a latching mechanism on the post.

[0074] FIGS. 28A-28C are top, side, and perspective views of a variationof the MTDS device having another latching mechanism on the post.

[0075]FIG. 28D is a view of cross-section 28D-28D from FIG. 28A.

[0076] FIGS. 29A-29C are edge, back, and side views of a variation ofthe MTDS device having two adjacent posts.

[0077] FIGS. 30A-30C are edge, back, and side views of another variationof the MTDS device having two aligned posts.

[0078]FIG. 31A is a top view of a variation of the insertion toolshowing the channel.

[0079]FIG. 31B is a view of cross-section 31B-31B from FIG. 31A showingan MTDS device and a side view of the support block.

[0080]FIG. 31C is a close-up view of the MTDS device and support blockfrom FIG. 31B.

[0081]FIG. 31D is a perspective view from the bottom showing theinsertion tool of FIG. 31A.

[0082]FIG. 31E is a perspective view from the top showing the insertiontool of FIG. 31A.

[0083]FIG. 32A is a top view of the insertion tool from FIG. 31A showingthe block assembly.

[0084]FIG. 32B is a view of cross-section 32B-32B from FIG. 32A showingthe MTDS device and a side view of the block assembly.

[0085]FIG. 32C is a close-up view of the MTDS device and block assemblyfrom FIG. 32B.

[0086]FIG. 32D is a perspective view from the bottom showing theinsertion tool of FIG. 32A.

[0087]FIG. 32E is a perspective view from the top showing the insertiontool of FIG. 32A.

DETAILED DESCRIPTION OF THE INVENTION

[0088] Our inventive device may be used when working with bone anchorsor a variety of soft tissues. The device is of the generalconfigurations shown in FIGS. 1A-1B and comprises a plurality ofattachment points (102) emanating from and preferably affixed to asupportive backing (100) that is a generally a porous material that mayhave the structure of a mesh, net, or lattice. The degree of flexibilityof the backing is determined by the material of construction, the shapeand dimensions of the device, the type and properties of theapproximated tissue, and the area of the body into which the device isplaced. For example, a tightly curved or mobile part of the body, e.g.,a joint, will require a more flexible backing, as would a tendon ornerve repair due to the amount of bending the device needs for theattachment. Also, depending on the type of material used, the thicknessof the backing as well as its width and length may determine theflexibility of the device. Furthermore, the backing may bepre-fabricated into different shapes as shown by the sharp corners (104)and rounded corners (106) in FIGS. 1C and ID. The fabricatedcross-sectional shape and dimensions of the mesh elements may vary topromote flexibility in regions of the backing. The cross-sectional shapeof the mesh elements may be chosen to minimize local compressive stressbetween the backing and surface it rests upon, or have rounded andfilleted edges to be less obtrusive to local circulation. The pluralityof attachment points distribute tension over the contact area betweenthe device and the tissue. The tension or forces are generally alsodistributed in the tissue and in the backing parallel to the interfacesbetween the tissue and the device.

[0089] Materials such as biodegradable polymers are preferably used toconstruct the backing and attachment points. Polymers synthesized frommonomers comprising esters, anhydrides, orthoesters, and amides areparticularly suitable for biodegradation. Examples of biodegradablepolymers are polyglycolide, polylactide, poly-α-caprolactone,polydiaxanone, polyglyconate, polylactide-co-glycolide, and block andrandom copolymers of these polymers. Copolymers of glycolic, lactic, andother α-hydroxy acids are highly desirable. Although we prefer to use asingle polymer or copolymer in a specific device, generally for ease ofconstruction, the invention is not so limited. An example of aninventive device may be made of two or more types of polymers orcopolymers (or molecular weights of the same polymer or copolymer). Forinstance, the backing material might be produced from a more flexiblepolymer and the points or tines of a stiffer material. The inflammatoryresponse to these polymers is minimal, and they have been safely used insuture materials, stents, drug delivery devices, orthopedic fixationdevices, and intestinal anastomotic rings.

[0090] Generally, we will refer to the attachment points as “tines” or“prongs”. These tines will refer both to points which are either sharp,i.e. able to separate tissue in a chosen use, or blunt, i.e. not able toseparate tissue in that use. The attachment points may also be referredto as “barbs” when those points have the retaining point shown inseveral of the Figures discussed below. Generally, the tines, prongs orbarbs penetrate into soft tissue and for a short distance. Theattachment points preferably do not traumatize tissue in any major way,e.g., by penetration through a selected area of tissue to meet anotherdevice on the opposite side of the tissue. For instance, the attachmentpoints generally do not penetrate the subject soft tissue more than0.100″. The attachment points may be considered to interlock withmodulation in the adjacent soft tissue rather than penetrate as by a pinor bolt.

[0091] As shown in FIGS. 2A-2E, the shape of the attachment points orbarbs may be varied depending, e.g., on the area of the body involvedand the type of tissue requiring closure or reapproximation. The tinesmay be canted or erect, but in a preferred variation, the generalstructure of the tines is of a rose thorn shape. As shown in FIG. 2A,the tines (200) have a wide base (202) that supports a projection (204)from the backing (206) against the degree of tension required to close awound or approximate tissue. For example, the attachment points may beerect tines (FIG. 2B-208), canted tines (FIG. 2C-210), canted arrowheads(FIG. 2D-212), canted hooks (FIG. 2E-214), or may have a single straightcross-section (FIG. 3G-311) that is nail-like, that does not vary overthe length of the prong, for example, similar in shape to a nail orsharpened pencil. Furthermore, the tip of the attachment points may bevaried as shown in FIGS. 3A-3D. The tips may be barbed (300 in FIG. 3A),arrowhead (double-barb) (302 in FIG. 3B), or cheese grater (304 in FIG.3D). A side view of the cheese grater tips is shown in FIG. 3D. Afaceted tip (303 in FIG. 3F) is shown. The faceted tip is especiallydesirable where the force to penetrate tissue is normal to the tissuesurface.

[0092] The connection of the prong to the backing may be rounded orfilleted, or the backing built-up around the prong, to reduce structuralstress concentrations. The backing or connecting structure may branchout away from the center, with each branch in turn branching to grappletissue in a distributed fashion. All edges of the device may be smoothexcept where sharpness is needed at the tip of the prong to pierce intothe tissue. Once the prongs pierce into the tissue, the tissue maybecome supported against the backing to minimize additional piercing orirritation by the prong tip. The device may be molded, stamped,machined, woven, bent, welded or otherwise fabricated to create thedesired features and functional properties.

[0093] The MTDS device may also have attachment points both on its frontside (305) and on a back side (307). As shown in FIGS. 3B and 3E, thefront and back sides have attachment points. The attachment points onthe front side (309) generally approximate tissue. The attachment pointson the back side (307) are auxiliary attachment points that may compriseforms such as round nubs (306) or pointed nubs (308). The auxiliaryattachment points may be used to secure or promote stable implantationof the device. Soft tissue may be gently pressed into open regions ofthe backing thereby helping to fix the device in place against bothunderlying and overlying tissue after the modulation or interlocking ofskin. FIG. 3H shows a reverse view of the nubs (310) on the back-side ofthe device (312). The attachment points on a two-sided device are notlimited to the combinations disclosed above, but may comprise anycombination of the previously mentioned attachment point shapes andorientations.

[0094] Structural variations can also be made to the backing of thedevice. As shown in FIG. 4A, the attachment points (400) may be placedthrough a plurality of openings in the backing (402) and secured to thebacking by a flange (404) or hub. In FIGS. 4B and 4C, the points (406)may also connect to strips (408) of the same material as the attachmentpoints which are then secured to a backing (410). The backing may alsobe comprised of a solid material (412) instead of a porous material.

[0095] The extent of porosity, or total surface area may be used tocontrol the absorption rate of the device, and may also be used tooptimize the strength-to-mass properties of the device, increasing thesection modulus of structural cross-sections per unit mass. The backingstructure may comprise partial folds, waves or grooves to help holdtissue against both surfaces of the backing. Regions of the backing mayfunction as suction cups to help hold tissue to the backing.

[0096] The density, distribution, length, and orientation of attachmentpoints on the backing may be modified depending on the type of woundclosure. Attachment points may be bent or curve gradually, with the tipdirected at an optimal angle relative to the backing to aid devicepenetration and stability within the tissue, and to reduce tissueirritation after device installation. Attachment points may be canted inone direction (500), such as toward the center of the device as shown inFIG. 5A. The attachment points may also be variously oriented, such astoward center (502) and erect (504), or toward center (502) and awayfrom center (506). It is within the scope of this invention to haveattachment points extending in any relative direction or orientation onthe backing. Or, as shown in FIG. 5D, the backing is divided into afirst area (508) and a second area (510). Attachment points in the firstarea (512) and second area (514) are canted toward each other. Theinventive device may also be sectioned into a plurality of areas, witheach section being variously oriented to another section.

[0097] In another variation of the invention, attachment points ofvarious lengths emanate from a single backing. For example, in FIG. 5E,the attachment points (515) are progressively shorter the closer theyare to the center of the device (516). The attachment points (515) mayalso become progressively shorter the farther they are from the centerof the device as shown in FIG. 5F. The variations shown in FIGS. 5B and5C have regions of attachment points canted toward the center (502) andwith other regions of attachment points with erect points (504 in FIG.5B) or canted away from the other end (506 in FIG. 5C) of the device.These variations are more difficult to dislodge when situated in an areaof the body having both to-and-fro movement, e.g., the inside of anelbow or back of the knee, or during placement of the device.

[0098] Portions of simple wound closures are shown in FIGS. 6A-6B. Thesewound closures involve placing the MTDS device (600) at the bottom ofthe wound, usually at the level of the sub-dermis (602). The edges ofthe wound (604) are approximated and then secured by fixation, e.g., bypressing, to the multiple attachment points (606). An example of theMTDS device placement in a laparotomy closure is shown in FIG. 7. Theincreased length of this incision requires placement of multiple devices(700).

[0099] A unique application of this device occurs in hernia repair inwhich case the biomaterials are not absorbable but rather are morelikely to be PTFE and POPU (“Gore-Tex”), polypropylene, or otherpermanent implant material. Once the hernia (801) is reduced, a MTDSdevice may be used to close the hernia defect by joining the edges ofthe separated fascia (804) as seen in FIGS. 8A and 8B. However, thedevice may also be modified to aid repair of a difficult herniaresulting from such circumstances as operating on an obese patient orlarge hernia, or having a wide fascial debridement where the fascialedges cannot be brought together. FIGS. 8C and 8D are variations of theinventive device that may be used in these cases. The attachment points(800) are secured to the ends of the backing (806) and are still used toadhere the device to tissue, but the points are spaced so that thecentral area of the backing is a flat surface without points (802) thatcovers the defect. The device in FIG. 8D is preferably used in anincisional hernia repair.

[0100] The MTDS device may also be constructed to reattach soft tissuesuch as tendons and ligaments to bone, as well as other soft tissue suchas cartilage and the free ends of vessels or nerves. In FIG. 9A, theinventive device functions similar to a clamp. Backings with attachmentpoints (900) are sides of a clamp that has a first end (901) and asecond end (904). The first end (901) grasps tissue and the second end(904) is an anchor for tissue. For example, a ruptured tendon (906) maybe fixed to the attachment points (908) of the first end of the clamp(901) and approximated to bone (902) with an anchor such as a pin ornail at the second end of the clamp (904), as seen in FIG. 9B. Aftermechanical fixation of the tissues, the biochemical phase of the woundhealing process will begin, eventually forming a natural union betweentendon and bone. Ligament and cartilage to bone unions using the MTDSdevice would undergo the same mechanical and biochemical processes.

[0101] Vascular anastomoses may also be constructed with the MTDSdevice. In FIG. 10B, the backing has a tubular shape (1000) withattachment points (1001) on the outside surface (1002). The outsidesurface (1002) has a first end (1003) and a second end (1005) thatopposes the first end (1003). The free ends of a vessel(s) (1004) areplaced over the device, creating an anastomosis (1006) that is securedby attachment points fixed into the wall of the vessels (1008). Theattachment points are preferably pointing towards the anastomosis(1006), with the attachment points on the first end (1003) being cantedtoward the second end (1005) and vice-versa. An axial view of therelationship of the attachment points (1010) to the vessel wall (1012)is shown in FIG. 10A.

[0102] Vessels and other soft tissue such as nerves, cartilage, tendons,and ligaments may also be joined as seen in FIGS. 11A and 11B. Two endsof tissue (1100) are brought and held together by the backing andattachment point construct (1102) being wrapped around the circumferenceof the tissue (1104). The attachment points (1106) are on the insidesurface of the backing (1107) and secure the union at a central region(1108) as seen in FIG. 11C. An axial, cross-sectional view of therelationship between the attachment points (1110) and tissue (1112) isshown in FIG. 11D. The resulting form is, i.e., a tubular structure thathas an inside surface (1107) with a central region (1108). Theattachment points on the inside surface (1106) may be canted toward thecentral region (1108). FIG. 11E shows the device with attachment points(1101) on the inside surface of the backing (1103) being wrapped aroundvessel ends to create an anastomosis (1105). Instead of being wrappedaround tissue, edges (1113) of tubular structures (1115) can also bejoined by externally placing 2 or more strips of backing of a MTDSdevice (1114) on approximated tissue as shown in the side views of FIGS.11F-11G, and the axial view in FIG. 11H. The attachment points (1117)also point toward the area of tissue approximation (1116).

[0103] FIGS. 11I-11M are additional variations of the invention whichvary the mechanisms used to improve device flexibility. In FIGS.11I-11K, the backing has areas of comparatively higher flexibility thanother areas of the backing. In an axial view of the variation in FIG.11I, the backing is equipped with hinges (1118) that allow bending ofthe backing (1120) around tubular soft tissue structures (1115). In asecond variation, the amount of material in the areas of the device thatfold (1122) is reduced as shown in FIGS. 11J-11K. Another variation isseen in FIGS. 11L-11M where attachment points (1124) of a device extendfrom a backing in the form of a coil or spring (1126). The edges of softtissue are approximated when the coil or a spring is reduced (1128).

[0104] Device for Brow and Face Lift Procedures

[0105] The device may also be used in soft-tissue remodeling, such as abrow-lift, shown in FIG. 12A. After dissection of the scalp (1200), theanterior scalp flap (1202) may be raised over the attachment points(1204) to lift the brow (1206). The ends of both the anterior flap(1202) and posterior flap (1208) may then be trimmed and fixed onto theattachment points (1204) to close the wound. The device may be securedto the skull (1210) by a screw (1212). The inventive device in thisexample may have a first end (1214) and a second end (1216), the firstend having a first area (1215) and the second end having a second area(1217). The first area (1215) and second area (1217) may have extendingattachment points (1204) or one or more openings (1218) to accommodate ascrew(s) (1212). The second area attachment points are canted toward thefirst end of the device as shown in FIG. 12B.

[0106] FIGS. 13A-13C show an alternative variation of the device whichmay be used in a brow-lift or similar surgical procedure. This devicemay generally be inserted under a patient's scalp while securelyinterlocking a small portion of the scalp to the device preferably via aplurality of attachment points. It may also be designed generally to layagainst the cranium in a low profile while secured to the cranium toprovide a brow lift. This variation comprises supportive backing (1300),which is shown substantially as an equilateral triangle, or in a deltashape. Backing (1300) may be any of a wide variety of triangular shapes,e.g., isosceles, etc. which functions to distribute planar loads equallyradiating from a small area, e.g., post (1304). Various alternativeshapes are discussed below in greater detail. Post (1304) isfunctionally for the maintenance of the device in place; other sectionsof the surgical procedure used to support the device in a specific partin the body. Post (1304) is placed on the side of the body opposite tothe tines.

[0107]FIG. 13A shows a front side view of supportive backing (1300).This variation may incorporate sharp corners at the triangle vertices,but preferably has radiused or rounded corners (1322) to aid in reducingabrasion and cutting in adjacent tissue. Anchoring post (1304) may belocated at one of the vertices of backing (1300). This anchoring post(1300) is shown in this variation as being substantially perpendicularto a plane of backing (1300), but may be other shapes as discussedbelow. Moreover, this device may be made of any of the materialsdiscussed herein, and is preferably comprised of a biodegradable orbioabsorbable material but is obviously not limited by material type.For instance, the device may be comprised of certain biologicalmaterials as well, e.g., collagen, hydroxyapatite from both natural andsynthetic sources, bone graft, or any combination or polymerized versionof these materials. FIG. 13D shows more clearly a perspective view of apreferred variation of the device shown in FIGS. 13A-13C.

[0108] In this variation, supportive backing (1300) may comprise atriangular form having a first end (1324) and a second end (1326). Thisvariation may typically be comprised of a front side, as shown in FIG.13A, and a back side, as shown in FIG. 13B. On the front side,preferably near a vertex of the triangular shape, is an anchoringregion. This region may comprise anchoring post (1304) as seen in FIGS.13A-13C, and this anchoring post (1304) may be a variety of shapes,e.g., a hook or an angled post, etc., but is preferably a perpendicularpost having a proximal and a distal end. Moreover, post (1304) ispreferably integral with backing (1300) so as to be formed from a singlepiece. This allows the device to be formed entirely into a singleintegral device by various manufacturing methods, e.g., injection or diemolding. Post (1304) may also be a separate structure fixedly attachedto backing (1360) by any variety of fastening methods, e.g., mechanicalfasteners or adhesives. The distal end of post (1304) may be chamfered(1318), as shown in FIGS. 13A and 13C; this would provide a degree oftolerance to enable the surgeon to easily locate and insert post (1304)into a receiving hole without sacrificing device integrity.

[0109] Post (1304) may preferably further comprise a locking deviceproximal of chamfer (1318). This locking device may utilize a variety oflocking mechanisms but is shown in this variation as front tab (1310)and partial collar (or rear tab) (1312). The locking mechanism ispreferably integral with post (1304) and may have a diameter which isgreater than a diameter of post (1304). In any case, partial collar(1312) is preferably elastically deformable, but may also be plasticallydeformable. Such deformability allows front tab (1310) and partialcollar (1312) to compress upon insertion into a patient's skull andsubsequently be able to spring back upon full insertion to provide afriction-fitted locking or securing feature. The locking device mayalternatively be a locking key mechanism or any conventional lockingmechanism. However, the locking mechanism may be omitted entirelybecause the device bases much of its stability, once inserted into apatient's cranium, upon the downward forces applied by the overlyingtissue. Thus, much of the forces acting on the device apply bendingloads on post (1304) rather than axially-oriented tensile loads.

[0110] As seen in FIG. 13A, post (1304) may incorporate a distal channelor cavity (1306) which may extend partially into the post from thedistal end or entirely through the post. This distal cavity (1306) mayhave a diameter which is smaller than the diameter of post (1304) andmay be aligned along an axis defined by post (1304) or may extend at anangle within post (1304). The cross-section 13E-13E of FIG. 13B is shownin FIG. 13E and shows more clearly the orientation of distal cavity(1306) within post (1304) for this variation. Distal cavity (1306) mayaid in reducing the amount of material used in the manufacture of thedevice, and is particularly useful in imparting a desirable degree offlexibility to post (1304) which may facilitate the insertion of post(1304) into the cranium.

[0111] Post (1304) may further define another hole, proximal cavity(1308), which may be used for tooling purposes as well as further addingto the flexibility of post (1304). Proximal cavity may extend fromchamfered proximal end (1320), which may also aid in tooling and helpingto prevent tissue abrasion. Proximal cavity (1308) may benon-concentrically located relevant to distal cavity (1306) and as shownin FIG. 13E, may extend partially into post (1304) or may be athrough-hole extending entirely through to the distal end of post(1304). Although proximal cavity (1308) may not necessarily be required,it may be utilized in a variety of ways. For example, proximal cavity(1308) may be used for aligning the device for tooling duringmanufacture, or it may also be used as a location to allow a user orsurgeon to manipulate the device using tools for placement of the devicewithin a patient. This proximal cavity (1308) may have a diameter, e.g.,about 1 mm, which is smaller than a diameter of post (1304).

[0112] In addition to proximal cavity (1308), the device may alsocomprise protrusions, tabs, or “ears” (1316), as seen in FIGS. 13A-13D.These protrusions (1316) are preferably integral with backing (1300) andmay generally be located anywhere on backing (1300), but is preferablylocated near first end (1324), and more preferably near post (1304).FIG. 13B shows protrusions (1316) located on either side of post (1304)and may provide a surface for manipulating the device by the doctor orsurgeon either during placement into the patient or during removal.

[0113]FIGS. 13A and 13C show the front and side views, respectively, ofattachment points (1302). As discussed above, attachments points (1302),also called “tines” or “prongs” are preferably integrally affixed tobacking (1300) but may also be separately attachable. They arepreferably located on the back side of backing (1300), i.e., the sideopposite of post (1304), and are preferably angled towards first end(1324). Moreover, individual attachment points (1302) maybe of varyingsizes and angles depending upon the desired securing effect. Attachmentpoints (1302) are discussed in greater detail above. In this variation,individual attachment points (1302) may vary in density, but areoptimally spaced relative to one another. Factors for optimizingattachment point relative placement may comprise the ease of securingtissue to attachment points (1302) and the distribution of loadsgenerated by the attached tissue over each of attachment points (1302).For instance, if attachment points (1302) were located too closely toone another, piercing the tissue would be difficult because of thedistribution of stresses on the tissue to be pierced by attachmentpoints (1302).

[0114] Another example may include having an increasing number ofattachment points (1302) placed on backing (1300) the farther they arelocated from post (1304) or front end (1324), where the greatest numberof attachment points are located in the direction of tensile loads onthe device. The spacing between individual points (1302) may befunctional in that the number, density, and placement of points (1302)are optimized to evenly distribute the loads, e.g., shearing forces andbending moments, generated by the attached scalp in a brow-liftprocedure. Moreover, attachment points (1302) are preferably configuredto penetrate partially through the soft tissue. For instance, thesharpness of attachment points (1302) are such that they allow easypenetration through the periosteum.

[0115]FIGS. 13B and 13D show supportive backing (1300) which may alsocomprise through-hole (1314) that is defined within backing (1300).Through-hole (1314) may generally be any shaped hole but is shown inthis variation as being slotted. Through-hole (1314) serves severalfunctions which may include reducing the amount of material used inmanufacturing the device, it may also add desirably to the flexibilityof backing (1300). Additionally, through-hole (1314) may be configuredas an alignment aid for tooling purposes. In addition to aligning,through-hole (1314) may also serve as a surface for a tool to graspduring device placement or removal. Flexibility is preferable because itenables backing (1300) to bend and conform more closely to the shape ofthe patient's cranium against which the device is placed. The degree offlexibility of backing (1300) may be tuned to a predetermined degreedepending upon several factors, e.g., the configuration and size ofthrough-hole (1314). Although shown as a slot, backing (1300) may definevirtually any through-hole shape which serves the functions discussedabove, i.e., increasing backing (1300) flexibility and aiding in toolalignment.

[0116] Method of Installing and Securing

[0117] FIGS. 14A-14D illustrate a preferable method of installing thedevice of FIG. 13A. The top of a patient's head is shown having ahairline (1402). As seen in FIG. 14A, the doctor or surgeon mayinitially make an incision (1404) in scalp (1414) preferably along asagittal plane defined by cranium (1400). The incision (1404) maytypically be done in the patient's hairline, if possible, to minimizeany visible scarring which may result. The length of incision (1404) istypically determined by the length or amount of scalp the patient maydesire or the surgeon may determine necessary to be lifted for asuccessful brow-lift procedure. This incision length may generally rangefrom about 1 to 2 cm but may be more or less depending on the desiredresults.

[0118] Once incision (1404) is made, a hole (1410) may be drilled withincranium (1400) at the incision second end (1408). Hole (1410) drilledinto cranium (1400) may typically be about 4.0 mm in diameter and may bemade by a conventional surgical drill (not shown). As shown in FIG. 14B,once the incision and hole are made, an MTDS device (1412) may beinserted between cranium (1400) and scalp (1414) at the incision firstend (1406) such that post (1304) faces towards cranium (1400) andattachment points (1302) face the underside of scalp (1414), i.e.,subperiosteal. FIG. 14C shows an outline of device (1412) placed atincision first end (1406) and beneath scalp (1414). Once device (1412)has been inserted, the portion of the scalp tissue to be raised (1416)is set on device (1412) via attachment points (1302). FIG. 15 shows across-sectional view of FIG. 14C where the tissue to be raised (1416)has been set on attachment points (1302). Once tissue (1416) is set, aforce (1500) may be applied to device (1412) preferably via post (1304).Force (1500) then draws the device (1412) and tissue (1416) towards hole(1410) which is configured to receive post (1304). As shown in FIG. 14D,once post (1304) is secured within hole (1410), force (1500) may beremoved, thereby leaving the brow desirably lifted.

[0119] Once device (1412) has been installed, attachment points (1302)and post (1304) undergo shear and bending loads from the lifted tissue(1416) pulling on the device (1412). However, these loads may decreaserapidly and approach zero as scalp (1414) heals. This decrease inloading may take up to about six weeks, but device (1412) may stay inplace beneath scalp (1414) for up to several years, with sufficientstrength for about six weeks, to prevent scalp (1414) from movingexcessively during the healing process and thereafter being absorbed bythe body, thereby removing the necessity for a second procedure toremove device (1412).

[0120] Variations on Attachment Points

[0121] FIGS. 16A-16D show a preferred variation for an attachment pointon a brow lift device. FIG. 16A shows a top view of a single attachmentpoint (1600) having a swept face (1606). FIG. 16B is a side view ofattachment point (1600) comprising distal pointed end (1602) andproximal base end (1604). Although any variations of attachment pointsdiscussed above may be used on the brow lift device, this variation ispreferable because it is able to readily pierce tissue through theperiosteum and simultaneously secure the tissue solidly by resisting anybending moments. In particular, swept face (1606) may be specificallyfaceted so that face (1606) is preferably oriented to be essentiallyperpendicular to the plane of the tissue or scalp being penetrated, eventhough the tine axis defined by attachment point (1600) may not beperpendicular to the plane of the tissue or scalp.

[0122] Attachment points of this variation may optionally bemanufactured individually and separately from the supportive backing andthen individually attached via backing attachment (1608) to the backingby a variety of fastening methods, e.g., friction fitting,adhesives,.etc. Optional backing attachment (1608) is seen in FIG. 16B,and more clearly in the back view of FIG. 16C. FIG. 16D shows thevariation more clearly in a perspective view. Attachment point (1600),as mentioned, may be manufactured separately and attached, but it ispreferably made integral with the MTDS device. Integrating theattachment point(s) (1600) with the backing not only provides uniformityin material type but also eliminates contact interfaces, which in turnmay provide superior material strength and resistance to bending.

[0123] As discussed above and as shown in FIGS. 13A-C, attachment points(1600) are preferably manufactured or attached so that they are allsubstantially canted in parallel towards the post. However, theattachment points are faceted such that the tips of attachment points(1600) are effectively perpendicular to the tissue to be penetrated.Attachment points (1600) may also be manufactured or assembled so thatthey point in different predetermined directions, depending on thedesired application. Furthermore, attachment points (1600) mayoptionally be made of varying sizes, as discussed in further detailabove.

[0124] Variations on Posts

[0125]FIG. 17A shows perspective 17A-17A from FIG. 13C of the distal endof post (1304). As shown, partial collar (1312) and front tab (1310)preferably comprises integral extensions or protrusions which act as alocking device. Both partial collar (1312) and front tab (1310) may beplastically deformable but is preferably elastically deformable. Theprotrusions provide opposing forces upon insertion into the skull toproduce a friction fit which secures the device in the patient. Partialcollar (1312) may essentially circumscribe any predetermined percentageof the cirumference of post (1304), provided that a sufficient fit isproduced.

[0126] Aside from partial collar (1312), post (1304) may alternativelyuse locking mechanisms comprising barbs and sub-cortical wings.Moreover, post (1304) may also be threaded so as to be rotated, orscrewed, into a threaded mating hole located within the patient'scranium.

[0127]FIG. 17B shows an alternative locking configuration from FIG. 17A.Here, partial collar (1312) is replaced by full collar (1700), which ispreferably integral with post (1304) and may also be plastically orelastically deformable. A further variation for a locking configurationis shown in FIG. 17C, in which first, second, and third tabs (1702),(1704), (1706), respectively, replaces partial collar (1312). Again,tabs (1702), (1704), (1706) are preferably integral and elasticallydeformable, although they may also be plastically deformable.Essentially any locking configuration may be utilized by a doctor orsurgeon depending upon the desired fit of post (1304).

[0128] Aside from varying locking mechanisms, the flexibility of thepost may be varied as well. As mentioned above, cavities may be disposedwithin the post to increase the post flexibility. FIG. 18A shows a backview of a variation of the cavity from FIG. 13B. As seen in FIGS. 18Band 18C, post (1800) is similar in most respects to the post shown inFIG. 13B. Post (1800) is illustrated extending from backing (1806),which is partially shown merely for clarity, with front tab (1802) andpartial collar (1804). However, FIG. 18A shows a single axial cavity(1900) disposed within and extending from a proximal end of post (1800).FIG. 19A shows a perspective view of post (1800) from FIGS. 18A-18Cwhere axial cavity (1900) is axially disposed within post (1800) andextends partially through. Cavity (1900) may extend through post (1800)perpendicularly to backing (1806) and concentrically along an axisdefined by post (1800), but it may also extend off-axis and at an angle,as shown in FIG. 13E. Furthermore, cavity (1900) may also extendentirely through post (1800) as a through-hole. FIG. 19B shows thecross-section 19B-19B taken from FIG. 18B clearly showing cavity (1900)extending partially into post (1800).

[0129] Another variation on the post is shown in FIG. 20. Latched post(2000) is shown having beveled latch (2002) pivotally disposed betweenpost members (2006). Latched post (2000) is shown extending from backing(2004) of which only a portion is shown for clarity. Beveled latch(2002) is preferably integrally attached at a proximal end so that latchdistal end (2010) is free to move. Beveled latch (2002) is alsopreferably beveled to provide a gripping surface once the device issecured in the patient. Because latch distal end (2010) may be free tomove, latch (2002) may be configured so that latch distal end (2010) maybe biased to extend angularly away from post members (2006). As post(2000) is inserted into a patient's cranium, latch distal end (2010) maybe urged towards post members (2006) to facilitate insertion bydepressing lever (2008), located at the proximal end of latch (2008).Once latched post (2000) has been positioned in the patient, lever(2008) may then be released, thus allowing latch distal end (2010) toprotrude angularly against the interior of the hole in the patient'scranium thereby providing a locking action.

[0130] A further variation of the post is shown in FIG. 21. Here, angledlatch post (2100) is preferably an angled latch (2102) having a beveledsurface and being integral with backing (2104) of which only a portionis shown for clarity. Angled latch (2102) may be integral with backing(2104) at the latch proximal end (2110) and disposed in-between postmembers (2106). Angled latch (2102) may further be biased so that thelatch distal end (2112) is angled away from backing (2104) and protrudesfrom in-between post members (2106). Accordingly, as angled latch post(2100) is inserted into the patient's cranium, latch distal end (2112)may similarly be urged towards post members (2106) to likewisefacilitate insertion. This movement or urging may be accomplished bydepressing latch extension (2108), which may be integrally attached toboth backing (2104) and angled latch (2102). Because latch extension(2108) may be attached in apposition to angled latch (2102), depressingit would thereby move latch distal end (2112) accordingly.

[0131] FIGS. 22A-22B show alternative variations of the post which mayinclude any of the features discussed herein. FIG. 22A shows roundedpost (2202) having a radiused distal end. FIG. 22B shows angled post(2204) which defines a predetermined angle, α, between a plane ofbacking (2200) and a longitudinal axis defined by angled post (2204).FIG. 22C shows another variation where a post is not used at all.Rather, a hole may be provided which has a diameter sufficient toreceive a separate fastener. In this variation, the fastener may be usedto secure backing (2200) to the patient's cranium through hole (2206).Fasteners may comprise any conventional fasteners, e.g., pins, nails,screws, and so forth. Alternatively, rather than securing the device viaa fastener through a hole, the hole (2206) may be omitted entirely andthe backing (2200) may be secured to the cranial surface via anadhesive, e.g., cyanoacrylate. Such an adhesive is preferablybiocompatible and provides sufficient bonding strength to support thetissue or scalp when lifted.

[0132] FIGS. 22D-22E show an alternative variation where the postcomprises radially expandable extensions. Expandable post (2208) ispreferably integral with backing (2200) to provide a uniform device.FIG. 22D shows expandable post (2208) having a first diameter, d₁. Thisdevice may be inserted into the patient's cranium and positioned in adesired location and configuration. Once positioned, the diameter may beexpanded by inserting expander device (2212), or using a tool configuredto expand radially, which pushes against the inner surfaces ofexpandable post (2208). The resulting expanded configuration is shown inFIG. 22E where expanded post (2210) has a second diameter, d₂, which islarger than first diameter d₁ and thus aids in securing the device inplace.

[0133] Variations on Drilled Holes

[0134] In securing a brow lift device within a patient, a hole may bedrilled into the cranium to receive the securing post of the device. Asmentioned above, the hole may be drilled by any number of conventionaldrills or specialized surgical drills. FIG. 23A shows a cross-sectionalview of a typical drilled hole (2304) in cranium (2300) which extendsdown into the cranial bone (2302). FIG. 23B shows another variationhaving angled hole (2306) which may be used to receive any of the postvariations discussed herein. A further variation is shown in FIG. 23Cwhere the hole may comprise keyed hole (2308). This variation showskeyed hole (2308) having two concentric grooves within the hole;however, any number of grooves or variations thereof may be incorporateddepending upon the desired hole profile and the tightness of the fit ofthe post within the hole.

[0135] Variations on Supportive Backing

[0136] FIGS. 24A-24D show a variation on the brow lift device backing.FIGS. 24A-24B show a top and side view of a device which is similar inmany aspects to the device as shown in FIGS. 13A-13C. The devicecomprises supportive backing (2400), post (2406), proximal cavity(2408), and attachment points (2402). However, this variation alsocomprises an additional leading attachment point (2404). This leadingattachment point (2404) may be incorporated as a redundancy to ensuretissue adhesion should the other attachment points (2402) slip or tearfrom the scalp tissue. FIG. 24C shows a perspective view of the devicewith leading attachment point (2404). And FIG. 24D shows a view ofcross-section 24D-24D from FIG. 24A. Proximal cavity (2408) is clearlyseen to extend partially into post (2406); but post (2406) mayincorporate other cavities and configurations as discussed above.

[0137]FIGS. 25A shows a top view of supportive backing (2500). Thisvariation is also similar in many aspects to the device as shown inFIGS. 13A-13C. The device may comprise post (2504), proximal cavity(2508), and through-hole (2510), which may be slotted or may compriseany other shape. Also, as seen in FIGS. 25B and 25C, the device may alsocomprise distal cavity (2506); however, this variation may haveseparatable attachment points which may be held in attachment pointlocations (2502). This variation may allow a doctor or surgeon to attachvariously shaped attachment points in a variety of orientations relativeto one another depending upon the desired result. Moreover, thisvariation may allow one to selectively attach attachment points atdesired attachment point locations (2502). Any number of attachmentspoints may be utilized; however, it is preferable that at least threeattachment points or tines spaced relatively apart be used to optimizethe holding capacity of the device to the tissue.

[0138]FIG. 26A shows a top view of an alternative variation forsupportive backing (2600) which is configured to be flexible and holdmultiple attachment points (2602). This particular variation may beconfigured to reduce the amount of material used and simultaneouslyincrease the flexibility to allow backing (2600) to conform to thepatient's cranium. Flexibility may be achieved via the use ofthrough-holes (2608) and slot (2610) which are seen in FIGS. 26A and26C. This variation also may incorporate post (2604) which may compriseanchoring tabs (2606), as seen in the side view of FIG. 26B, to aid insecuring the device to the cranium.

[0139]FIG. 27A shows a top view of another alternative variation forsupportive backing (2600) which is similar in most aspects to the deviceshown in FIG. 26A. As seen in FIGS. 27A-27C, particularly 27B thisvariation incorporates latched post (2700). Post (2700) may utilize alatching mechanism similar to the latched posts illustrated in FIGS.20-21. This particular post comprises latch (2702) which is shown ashaving a hooked distal end.

[0140] FIGS. 28A-28C shows top, side, and perspective views of a furthervariation for supportive backing (2600). This variation illustrateslatched post (2800) having beveled latch (2802) which may be similar tothe latching device shown in FIG. 21. FIG. 28D shows a view ofcross-section 28D-28D taken from FIG. 28A. The latched post (2800) andthe configuration of latch (2800) may be seen where latch (2802) ispreferably integral with backing (2600).

[0141] In addition to alternative backings, variations of MTDS deviceshaving multiple posts may also be utilized. FIG. 29C shows a variationalso having attachment points (2902) and through-hole (2906). As seenfurther in FIGS. 29B, this variation may comprise a configuration wheretwo posts (2904) are attached to backing (2900). Posts (2904) arepreferably attached integrally to backing (2900) and may be orientated,as seen in FIG. 29A, such that posts (2904) are aligned along an x-axis.The addition of a second post along the x-axis may aid in increasing thedevice resistance to rotation about the posts (2904) once it is insertedinto the cranium. This added rotational stability may then allow thedevice to be inserted at various angles within the cranium relative tothe tissue to be lifted depending upon the desired results.

[0142] A further alternative backing having multiple posts is shown inFIG. 30A. Also seen in this variation are attachment points (3002)attached to backing (3000) and through-hole (3006) defined withinbacking (3000). However, this variation comprises two posts (3004),which are preferably integral with backing (3000), aligned along ay-axis. The additional post along the y-axis may aid greatly in alsoincreasing the device resistance to rotation about posts (2904). Thisvariation likewise may allow the device to be inserted at various angleswithin the cranium depending upon the desired results and the angle ofdesired lift. Furthermore, this particular variation may be desirablewhere cranial physiology would prevent two adjacent posts from beingsecured into the cranium.

[0143] Placement Tools

[0144] Many of the variations on the brow lift device may be insertedand secured into a patient in a number of ways. One such method involvesusing an insertion tool of a type shown in FIG. 31A. This variationshows a top view of such a tool which may serve several functions. Thistool comprises manipulation handle (3100), by which a doctor or surgeonmanipulates, for example, the device of FIGS. 13A-13C. As shown furtherin FIG. 31B, cross-section 31B-31B from FIG. 31A, handle (3100) may behinged by any conventional methods but shown here as bolt hinge (3104).At a distal end of handle (3100) are grasping members (3102). Thesegrasping members (3102) may generally be designed to have opposingmembers which may be urged together or apart, i.e., to close or open; ashandle (3100) is urged about hinge (3104).

[0145] To prevent uncontrolled rotation of handle (3100) and to providea way of securely grasping the device, handle (3100) may also comprise alocking mechanism which may hold handle (3100) and grasping members(3102) in a desired position. Grasping members (3102) are preferablydesigned or configured to securely hold the supportive backing (1300)relatively planar with grasping members (3102) such that attachmentpoints (1302) face away from the patient during insertion. It is furtherpreferable that grasping members (3102) securely hold the MTDS devicevia anchoring post (1304) to allow easy handling and insertion. As seenin FIG. 31B, grasping members (3102) are preferably angled relative to aplane defined by handle (3100) at a predetermined angle, α, to furtherallow easy insertion of the device.

[0146]FIG. 31C shows a close-up cross-sectional view of the distal endof the insertion tool. As shown, also attached to hinge (3104) issupport block (3106). Support block (3106) is preferably configured toattach to handle (3100) at hinge (3104) yet still allow rotationalmovement of the tool about hinge (3104). Support block (3106) alsopreferably defines channel (3110) through a top surface of support block(3106), as shown in FIGS. 31A-31C. Channel (3110) may run substantiallyparallel relative to a symmetrical axis defined by the insertion tool.Support block (3106) may be supported by support post (3108) which mayhelp in preventing rotation of support block (3106) about hinge (3104)as well as maintaining a position of the block relative to handle(3100).

[0147] Further seen in FIG. 31C, channel (3110) in support block (3106)is preferably angled relative to the plane defined by handle (3100).While grasping members (3162) are angled at an angle, a, relative tohandle (3100), channel (3110) may be angled relative to grasping members(3102) at a desired angle, β. This angle β is preferably similar to theangle formed by attachment points (1302) relative to supportive backing(1300). Angling channel (3110) may allow a mating block, described belowin further detail, to run along channel (3110) and press against thetissue to be lifted against attachment points (1302). A block pressingagainst tissue to be set on attachment points (1302) allows for optimalpiercing of the tissue if the force applied by the block is in the sameor similar angle or direction as attachment points (1302).

[0148]FIGS. 31D and 31E show a bottom and a top perspective view,respectively, of the insertion tool from FIG. 31A grasping an device. Asseen in FIG. 32A, the same insertion tool from FIG. 31A is shown withthe addition of depressible block (3200) mated with support block(3106). Depressible block (3200) may be mated with support block (3106)via channel (3110), into which mating slide (3204) may be inserted.Slide (3204) may be an integral extension of depressible block (3200)and is preferably configured to allow a degree of tolerance relative tochannel (3110) so that depressible block (3200) may slide freely or whenurged via channel (3110) and mating slide (3204), as shown by the arrowin FIG. 32B.

[0149]FIG. 32B also shows a cross-section 32B-32B from FIG. 32A.Depressible block (3200) further illustrates depression region (3202),which may be a slight indentation defined in the surface facing awayfrom the patient during insertion. Depression region (3202) may serve asa locator for the optimal region the physician may depress to forcedepressible block (3200) and contact surface (3206) downward against thetissue and attachment points (1302) in order to set, or pierce, thetissue. FIG. 32C shows a close-up cross-sectional view of the distal endof the insertion tool with depression block (3200) inserted. Contactsurface (3206) is the surface which ultimately presses the tissueagainst attachment points (1302) and is preferably relatively parallelwith the plane defined by grasping members (3102) and supportive backing(1300) to present the greatest surface area pressing against the tissue.Depressible block (3200) is further preferably configured to slide orrun along the same angle, β, at which support block (3106) is set toprovide a planar contact surface (3206) to press against the tissue atan optimal angle, which may be at the same or similar angle asattachment points (1302), as discussed above.

[0150]FIGS. 32D and 32E show a bottom and a top perspective view,respectively, of the insertion tool from FIG. 32A with depressible block(3200) set in channel (3110). Although the placement tool has beendescribed with depressible block (3200), the tool may also be usedwithout a block for depressing the tissue or scalp against theattachment points (1302). Rather, affixing or setting the tissue mayalso be done by hand, i.e., simply depressing the tissue with the handand fingers against attachment points (1302).

[0151] We have described this invention by example and by description ofthe physical attributes and benefits of the structure. This manner ofdescribing the invention should not, however, be taken as limiting thescope of the invention in any way.

We claim:
 1. An implantable tissue approximation device comprising: a) asupportive backing adapted to conform to a surface in contact with saidbacking; b) a plurality of attachment points extending from saidbacking; and c) an anchoring region integral with said backing.